Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway.
Acta Orthop. 2011 Oct;82(5):538-44. doi: 10.3109/17453674.2011.618914. Epub 2011 Sep 6.
We performed a randomized study to determine the migration patterns of the Spectron EF femoral stem and to compare them with those of the Charnley stem, which is regarded by many as the gold standard for comparison of implants due to its extensive documentation.
150 patients with a mean age of 70 years were randomized, single-blinded, to receive either a cemented Charnley flanged 40 monoblock, stainless steel, vaquasheen surface femoral stem with a 22.2-mm head (n = 30) or a cemented Spectron EF modular, matte, straight, collared, cobalt-chrome femoral stem with a 28-mm femoral head and a roughened proximal third of the stem (n = 120). The patients were followed with repeated radiostereometric analysis for 2 years to assess migration.
At 2 years, stem retroversion was 2.3° and 0.7° (p < 0.001) and posterior translation was 0.44 mm and 0.17 mm (p = 0.002) for the Charnley group (n = 26) and the Spectron EF group (n = 74), respectively. Subsidence was 0.26 mm for the Charnley and 0.20 mm for the Spectron EF (p = 0.5).
The Spectron EF femoral stem was more stable than the Charnley flanged 40 stem in our study when evaluated at 2 years. In a report from the Norwegian arthroplasty register, the Spectron EF stem had a higher revision rate due to aseptic loosening beyond 5 years than the Charnley. Initial stability is not invariably related to good long-term results. Our results emphasize the importance of prospective long-term follow-up of prosthetic implants in clinical trials and national registries and a stepwise introduction of implants.
我们进行了一项随机研究，以确定 Spectron EF 股骨柄的迁移模式，并将其与被广泛认为是植入物比较金标准的 Charnley 柄进行比较，后者有大量的文献记录。
150 名平均年龄为 70 岁的患者被随机分为两组，单盲，分别接受骨水泥固定的 Charnley 带法兰 40 单体、不锈钢、vaquasheen 表面股骨柄（头径 22.2mm）（n=30）或骨水泥固定的 Spectron EF 模块化、哑光、直形、带颈钴铬股骨柄（头径 28mm）和近端三分之一粗糙化的股骨柄（n=120）。对患者进行了 2 年的重复放射立体测量分析以评估迁移情况。
2 年后，Charnley 组（n=26）和 Spectron EF 组（n=74）的柄后倾分别为 2.3°和 0.7°（p<0.001），后向平移分别为 0.44mm 和 0.17mm（p=0.002）。Charnley 组和 Spectron EF 组的下沉分别为 0.26mm 和 0.20mm（p=0.5）。
在我们的研究中，2 年后 Spectron EF 股骨柄比 Charnley 带法兰 40 柄更稳定。在挪威关节置换登记处的一份报告中，Spectron EF 柄由于无菌性松动，在 5 年后的翻修率高于 Charnley 柄。初始稳定性并不总是与良好的长期结果相关。我们的结果强调了在临床试验和国家登记处对假体植入物进行前瞻性长期随访以及逐步引入植入物的重要性。
